ACTIVA
Report
- Report Number
- 3004209178-2012-06780
- Event Type
- Injury
- Date Received
- August 10, 2012
- Report Date
- July 14, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4).
LEAD MODEL 3389S-40, LOT # V118068, IMPLANTED: (B)(6) 2008, EXPLANTED: NA; LEAD MODEL 3389S-40, LOT # V118068, IMPLANTED: (B)(6) 200, EXPLANTED: NA; EXTENSION MODEL 7482A40, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: NA; EXTENSION MODEL 7482A40, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: NA; PROGRAMMER MODEL 37642, SERIAL # (B)(4); ADAPTOR MODEL 64002, LOT # UNKNOWN, IMPLANTED: (B)(6) 2012.
(B)(4).
ADDITIONAL INFORMATION: IT WAS CONFIRMED THAT THE PATIENT RECOVERED.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT AFTER ABOUT SIX WEEKS THE PATIENT'S CT SCAN RETURNED TO NORMAL. THE DBS SYSTEM WAS TURNED BACK ON UNEVENTFULLY AND HAD SINCE WORKED WELL. THE PATIENT FELT THE CHANGE CAME ABOUT AFTER SEVERAL BAD FALLS, AND IT WAS HYPOTHESIZED THAT A HEAD INJURY COMBINED WITH THE ELECTRODE TO LEAD TO THE AREA OF LOW DENSITY. IT WAS CONCLUDED THAT THE PATIENT SEEMED TO HAVE RECOVERED WELL.
IT WAS REPORTED THAT THE PATIENT WENT IN FOR A BATTERY REPLACEMENT. PRIOR TO IMPLANT, THE NEW INS WAS PROGRAMMED BUT LEFT IN AN ''OFF'' CONDITION. WHEN THE DEVICE WAS IMPLANTED AND INITIALLY TURNED ON THE SETTINGS CAME BACK NORMAL. THE PATIENT WAS TURNED UP TO 4.0V ON THE LEFT STN AND 2.6V ON THE RIGHT STN, HOWEVER, ONE MINUTE LATER THE DEVICE WAS TURNED DOWN TO 2.0V ON BOTH SIDES. THIS WAS PRIOR TO TRANSPORT TO RECOVERY AREA, AND THE DEVICE WAS LEFT AT 2.0V UNTIL LATER IN THE MORNING SO THAT THE HCP COULD TITRATE THE AMPLITUDE UP PRIOR TO THE PATIENT BEING DISCHARGED. IT WAS NOT KNOWN WHAT SETTINGS THE PATIENT WAS TITRATED TO. WITHIN DAYS OF THE REPLACEMENT THE PATIENT'S FAMILY NOTICED A SIGNIFICANT CHANGE IN HIS MENTAL STATUS; HE WAS ANGRY, AGITATED, AND IMPULSIVE. THERE HAD BEEN NO PROBLEMS AT ALL WITH THE REPLACEMENT OR WITH THE PATIENT'S THERAPY. AN ADDITIONAL CHANGE TOOK PLACE STARTING (B)(6) 2012 WHEN THE PATIENT BEGAN FALLING FLAT ON HIS FACE (A DEAD FALL) APPROXIMATELY THREE TIMES PER HOUR. IN THE MORNING HOURS OF (B)(6) 2012 THE PATIENT WAS LETHARGIC, WEAKENED, DID NOT OPEN EYES, AND COULD NOT GET UP TO USE THE BATHROOM. AT THIS TIME THE PATIENT WAS BROUGHT TO THE EMERGENCY ROOM AND HOSPITALIZED. A CT SCAN AND VASCULAR IMAGING STUDY FOUND NO SIGNS OF A STROKE, HOWEVER, THERE WAS INFLAMMATION NEAR THE LEADS (NOT ENCAPSULATING, BUT NEXT TO IT) THAT TRACKED DOWN TO THE BRAIN STEM, AND APPEARED TO BE WORSE ON THE RIGHT SIDE. IT WAS NOTED THAT THE AREA OF IRRITATION WAS VERY DIFFERENT FROM REPORTED CASES OF ELECTRICAL DAMAGE. AN ADDITION DOCTOR REVIEWED THE SCAN AND DID NOT NOTE INFECTION OR CURRENT DENSITY ISSUES. IT WAS NOTED THAT WHEN THE PATIENT FIRST CAME TO THE ER HIS INS WAS INITIALLY TURNED DOWN FROM 5.0V TO 4.6V IN AN EFFORT TO SEE IF HIS SYMPTOMS WOULD RESOLVE. WHEN THEY DID NOT, THEY TURNED THE DEVICE OFF. THE INS WAS TURNED TO ZERO VOLTS AND TURNED OFF ON (B)(6) 2012. IT WAS NOTED THAT THE PATIENT HAD SEVERE PARKINSON'S, AND EXPERIENCED A RETURN IN SYMPTOMS. WITH THE INS OFF INFLAMMATION HAD NOT REDUCED, AND THERE HAS BEEN NO SIGNIFICANT IMPROVEMENT OF SYMPTOMS. ON (B)(6) IT WAS REPORTED THAT A NEUROLOGIST TOLD THE PATIENT'S DAUGHTER THAT POSSIBLY ANOTHER PROCESS WAS TAKING PLACE THAT WAS NOT RELATED TO THE IMPLANTED DEVICES. IT WAS NOTED THAT AN IMPEDANCE CHECK WAS NORMAL, WITH ALL CONTACTS BETWEEN 800 AND 850 OHMS. THE HCP PLANNED TO LEAVE THE DBS OFF FOR 4-6 WEEKS AND ADJUST THE PATIENT'S MEDICATION TO TREAT HIS PARKINSON'S. ON (B)(6), IT WAS REPORTED THAT THE PATIENT STATUS WAS NO WORSE THAN THE PAST FEW DAYS, BUT HE WAS STILL VERY SYMPTOMATIC FROM PD WITHOUT BEING ABLE TO RECEIVE DBS THERAPY. A REPEAT CT SCAN WAS NO WORSE, BUT NOT SUBSTANTIALLY IMPROVED COMPARED TO THE ORIGINAL. THE PATIENT HAD A LEFT HEMIPARESIS THAT CORRESPONDED TO THE RIGHT-SIDED REACTIVE CHANGES ON THE CT; AND ALSO MAY HAVE HAD A PSEUDO-BULBAR AFFECT. IT WAS REPORTED THAT THE PATIENT MAY ALSO REQUIRE A PERCUTANEOUS GASTROSTOMY FEEDING TUBE PROCEDURE BECAUSE HE WAS SO HYPOKINETIC, AND TO ASSIST WITH NUTRITION AND MEDICATION ADMINISTRATION. PREVIOUS LITERATURE REPORTS OF CASES OF SYMPTOMATIC EDEMA / SWELLING AROUND DBS LEADS DID NOT CORRESPOND TO THIS CASE, WITH ONSET OVER 10 DAYS POST-INS-REPLACEMENT AND FOUR YEARS AFTER CONTINUOUSLY SUCCESSFUL DBS THERAPY. IMPEDANCE CHECKS WERE REPEATEDLY OK ON ALL 8 CONTACTS DURING MULTIPLE TESTS. THE HCP WAS CONFIDENT THAT THE INS WAS ''RIGHT SIDE UP'' AND THAT ALL THE CONNECTIONS WERE PROPER. THE HCP PLANNED TO EVENTUALLY RESTART THERAPY AT LOW AMPLITUDES AND WITH VERY SLOW TITRATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS DETERMINED THAT THE ISSUE WAS DUE TO THE PATIENT HAVING AN INFECTION THAT EXACERBATED HIS DYSTONIA SYMPTOMS.
ADDITIONAL INFORMATION FROM THE PATIENT'S PHYSICIAN STATED THE 'PSEUDOBULBAR AFFECT WAS NOT MENTIONED IN THE CHART AND WAS NOT INDIC ATED IN THE PATIENT'S PROBLEM LIST/DIAGNOSIS LIST.'
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| O |